Centricity Universal Viewer Zero Footprint Client
Medical device recall Z-0641-2019. Published in FDA’s Enforcement Report on Dec 26, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 26, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 508 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and vertically, the orientation markers appear correctly on the image to which they were applied. However, once new image rendering happens on this image or series (with scrolling; playing cin¿; maximizing or changing viewports/layouts; or synchronizing viewports and resizing the browser), the new image orientation is correctly maintained but the display of orientation markers can become incorrect. Issue #2 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a, SP8.0.2, SP9 and SP9.0.1. When an image in a series is flipped and then rotated in Zero Footprint Viewer (ZFP), the orientation markers appear correctly on the image to which they were applied. However, once you navigate to another image in the series and the image you navigated to has a different orientation than the prior image from which you navigated, the new image orientation is correctly maintained but the display of orientation markers can become incorrect.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect.
508 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number UDI 4532-2-Centricity Universal Viewer Zero Footprint / ZFP-01889426 (01)00840682102988(10)6.0SP82093796001D 4532-2-Centricity Universal Viewer Zero Footprint / ZFP-01889426 (01)00840682102988(10)6.0SP82093796001D…
Every code shown here, 1,994 characters
Serial Number UDI 4532-2-Centricity Universal Viewer Zero Footprint / ZFP-01889426 (01)00840682102988(10)6.0SP82093796001D 4532-2-Centricity Universal Viewer Zero Footprint / ZFP-01889426 (01)00840682102988(10)6.0SP82093796001D 10213-1-Centricity Universal Viewer Zero Footprint / ZFP-01815213 (01)00840682102988(10)6.0SP72093796001D 10711-1-Centricity Universal Viewer Zero Footprint / ZFP-01970566 (01)00840682102988(10)6.0SP72093796001D 100620-2-Centricity Universal Viewer Zero Footprint / ZFP-00099694 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00105531 (01)00840682102988(10)6.0SP7.0.22093796001D 3730-1-Centricity Universal Viewer Zero Footprint / ZFP-01803680 (01)00840682102988(10)6.0SP7.0.22093796001D 3730-1-Centricity Universal Viewer Zero Footprint / ZFP-01803680 (01)00840682102988(10)6.0SP7.0.22093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00102068 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00105530 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00105531 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00105531 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-02025410 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-02025461 (01)00840682102988(10)6.0SP9.0.12093796001D 105412-2-Centricity Universal Viewer Zero Footprint / ZFP-01978386 (01)00840682102988(10)6.0SP92093796001D 3846-2-Centricity Universal Viewer Zero Footprint / ZFP-01613236 (01)00840682102988(10)6.0SP72093796001D 2317-3-Centricity Universal Viewer Zero Footprint / ZFP-00165279 (01)00840682102988(10)6.0SP7.0.22093796001D 2317-3-Centricity Universal Viewer Zero Footprint / ZFP-00165278 (01)00840682102988(10)6.0SP7.0.22093796001D 1202-8-Centricity…
FDA’s list runs to 53,981 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 9, 2018.
- FDA classified it on Dec 19, 2018.
- FDA’s Enforcement Report published it on Dec 26, 2018.
- FDA terminated it on May 18, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 53,981 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.